WO2002102455A1 - Matrice et systeme de stimulation miniatures implantables conçus pour la stimulation de la paupiere - Google Patents
Matrice et systeme de stimulation miniatures implantables conçus pour la stimulation de la paupiere Download PDFInfo
- Publication number
- WO2002102455A1 WO2002102455A1 PCT/US2002/017852 US0217852W WO02102455A1 WO 2002102455 A1 WO2002102455 A1 WO 2002102455A1 US 0217852 W US0217852 W US 0217852W WO 02102455 A1 WO02102455 A1 WO 02102455A1
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- WO
- WIPO (PCT)
- Prior art keywords
- eyelid
- signal
- electrode
- stimulator
- implantable
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0526—Head electrodes
- A61N1/0543—Retinal electrodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
Definitions
- This invention relates to a prosthetic medical device and methods, and more particularly to implantable eyelid devices and methods for controlling the opening and closing of an eyelid.
- the structure of the eyelid 56 is shown in FIG. 1.
- the muscle fibers of the orbicularis oculi 50 surround the palpebral fissure, which is the slit between the upper and lower lids.
- the function of the orbicularis oculi 50 is to close the eye.
- the palpebral part 52 sweeps in curves in the upper and lower eyelids. On contraction, the eyelids are closed gently.
- the orbital part 54 sweeps in concentric curves in the forehead and cheek as a flat, thin sheet of muscle. Contraction lowers the eyebrow, and when this muscle contracts with the palpebral part 52, the eyes are squeezed tightly shut.
- the orbicularis oculi 50 can fail to contract in a damaged, partially denervated eyelid, thus there is a loss of eyelid blinking.
- the levator palpebrae superioris 58 functions to elevate the upper eyelid, thus opposing the orbicularis oculi 50 muscle.
- the frontalis- occipitalis 60 elevates the eyebrows and is a dilator of the palpebral fissure.
- U.S. Patent Nos. 4,799,487 and 5,843,147 presents an implantable electrode approach to solving this problem.
- the electrode for the system must be designed such that it can be easily implanted, is chronically stable once implanted, and provides electrical stimulation without causing pain to the patients. For example, it is important to avoid stimulation of surrounding facial muscles or nearby sensory nerves.
- Current known electrodes do not provide all of such functionality as applicable to the eyelid, eye, and surrounding area.
- U.S. Patent No. 6,275,735 describes normal retinal cell function as a photochemical reaction converting light energy to an electrical impulse that travels to the brain and vision occurs.
- AMD age-related macular degeneration
- ATP Adenosine triphosphate
- protein synthesis drops, the electrical resistance goes up, and cell membrane electrical potential goes down.
- the cells may go dormant for a time before they die.
- microcurrent stimulation will help rejuvenate the cells in the retina to slow or stop degeneration of the eye due to AMD. With the proper microcurrent stimulation waveform and therapy procedures, AMD may be slowed or stopped in a large number of people suffering from the disease.
- the apparatus of the instant invention is an implantable miniature stimulator and/or sensor for eyelids.
- the device is surgically implanted on or near a nerve or muscle that controls the blinking function of an eyelid.
- Electrical pulses are transmitted from a control device that may be located remotely from the stimulator, and which may be implanted in the body.
- the stimulating electric pulses travel along an electrically insulated cable that contains a number of very small diameter wires.
- the wires pass through an electrically insulating silicone body and down a leaflet body where they are attached to an electrode.
- the electrode rests on the nerve or muscle to be stimulated.
- an electrical stimulating pulse is transmitted to the electrodes, at intervals on the order of several times per minute, which causes the paralyzed eyelid to open or close for normal blinking.
- the feedback signal in a closed loop control case may be generated in response to a sensor on a functional eyelid, responsive to a neurostimulator muscular signal, which is then used to trigger stimulation of the paralyzed eyelid.
- the input stimulation signal may be adjusted to give a satisfactory and consistent response.
- FIG. 1 illustrates the structure of the human eyelid.
- FIG. 2 illustrates a top view of the eyelid stimulator.
- FIG. 3 illustrates a side view of the eyelid stimulator of FIG. 2.
- FIG. 4 illustrates a cross-sectional view of the stimulating and neutral electrodes of the eyelid stimulator through section 4-4 of FIG. 2.
- FIG. 5 illustrates simplified top view electrode connection schemes.
- FIG. 6 illustrates a top view of an alternative eyelid stimulator.
- FIG. 7 illustrates the implanted eyelid stimulator connected to an implanted miniature electric generator.
- FIG. 8 illustrates a control scheme for an eyelid stimulator.
- FIG. 9 illustrates a master control scheme for an eyelid stimulator.
- FIG. 10 illustrates a closed loop control scheme for an eyelid stimulator.
- FIG. 1 illustrates relevant facial muscles relating to eyelid stimulation.
- An eyelid stimulator 2 and a controller 3 are illustrated in a preferred implant orientation to a paralyzed eyelid 9.
- Implantable eyelid stimulator 2 is generally illustrated in FIG. 2.
- the overall approximate dimensions of the eyelid stimulator 2, excluding insulated signal cable bundle 14 and insulated neutral cable bundle 16, are less than about 20 mm in length by less than about 10 mm in width, and, as shown in FIG. 3, less than about 0.50 mm in thickness.
- the eyelid stimulator 2 contains an electrode array.
- Leaflet bodies 4 hold electrically conductive signal electrodes 6 and neutral electrodes 7 that contact a nerve or a muscle that is to be stimulated.
- the signal electrodes 6 pass a stimulating electrical signal to the nerve or muscle, with the neutral electrodes 7 also contacting the nerve or muscle, thereby completing the stimulation circuit.
- neutral electrode and “signal electrode” is arbitrary, because the neutral electrodes 7 and the signal electrodes 6 will preferably be reverse biased on each cycle.
- the eyelid stimulator 2 may be used as a sensor to detect signals and to transmit these signals to a remotely located signal receiver and processor.
- the eyelid stimulator 2 is similar to those disclosed in U.S. Patent Nos. 6,315,721 and 6,208,894, which are incorporated in their entirety by reference herein.
- a feature of this preferred embodiment is the flexibility of leaflet bodies 4, which are free to move with the eyelid and the stimulated muscle.
- the signal electrodes 6 and the neutral electrodes 7 are located in the leaflet body 4.
- Apertures 30 are located in one surface of the leaflet body 4 to expose the signal electrodes 6 and the neutral electrodes 7 to the living tissue, thereby allowing electrical contact between the living tissue and the signal electrodes 6 and the neutral electrode 7.
- Electrode lead body 10, FIG. 2 is joined to the leaflet bodies 4 such that a joint 12 is formed between the leaflet bodies 4, near the attachment of the leaflet bodies 4 and the electrode lead body 10.
- Anchor holes 20 in the electrode lead body 10 or leaflet bodies 4 preferably provide locations where attachments, such as sutures, may be placed for anchoring the eyelid stimulator 2. Alternately, living tissue may grow into the anchor holes 20, forming an attachment to the living tissue.
- the insulated signal cable bundle 14 and the insulated neutral cable bundle 16, shown in FIG. 2 are each connected to a remotely located implanted miniature electric generator 66 (see FIG. 7) that produces electrical impulses that in turn stimulate the nerve or muscle that causes the eyelid to blink.
- the electric generator 66 could be a microstimulator or it could be another type of stimulator.
- the strands of wire comprising the insulated signal cable bundle 14 or insulated neutral cable bundle 16 are made of a highly conductive metal that is benign in the body, such as MP35N, stainless steel, iridium or an alloy of iridium, platinum or an alloy of platinum, such as platinum-iridium.
- each strand of the wire has a diameter of approximately 0.001 inches.
- insulated signal cable bundle 14 and insulated neutral cable bundle 16 are comprised of approximately 19 strands of platinum-20 weight percent iridium wire.
- the insulated signal cable bundle 14 and the insulated neutral cable bundle 16 are electrically isolated from each other and from the environment in the living tissue by electrical insulation 32, which is preferably an outer covering of Teflon ® , a registered trademark of E.I. du Pont de Nemours and Company, Wilmington, Delaware.
- electrical insulation 32 which is preferably an outer covering of Teflon ® , a registered trademark of E.I. du Pont de Nemours and Company, Wilmington, Delaware.
- the signal electrodes 6 and the neutral electrodes 7 are made of a biocompatible material, such as stainless steel, iridium or an alloy of iridium, platinum or an alloy of platinum, such as platinum-iridium, and in a preferred embodiment, they are platinum-10 weight percent iridium.
- the signal electrodes 6 and the neutral electrodes 7 are essentially identical physically and are approximately 0.50 mm thick and 0.80 mm in diameter. While the signal electrodes 6 and the neutral electrodes 7 are shown in FIGS. 2 and 3 with the preferred round shape, the signal electrodes 6 and the neutral electrodes 7 may be of any shape, for example, rectangular, square, oval, or round, etc.
- the eyelid stimulator 2 of FIGS. 2 and 3 is preferably oriented in the eyelid such that the leaflet bodies 4 lay across the orbicularis oculi muscle 50 (see FIG. 1). Accordingly, as the muscle contracts due to the applied electrical stimulation, the flexible leaflet bodies 4 of the present invention move freely with the muscle.
- FIG. 3 illustrates the eyelid stimulator 2 from a side view and illustrates the insulated neutral cable bundle 16 entering the electrode lead body 10 at seal 18.
- the electrode lead body 10 is comprised of a top layer 24 and a bottom layer 26 that are joined together.
- the joint 12 is formed where the leaflet bodies 4 join the electrode lead body 10.
- FIG. 5a illustrates a simplified view of the electrodes connection scheme, where the signal electrodes 6 operate in unison and where the neutral electrodes 7 operate in unison.
- FIG. 5b illustrates a simplified view of the electrodes connection scheme, where an alternative embodiment preferably has a common insulated signal cable bundle 14 that is connected to all of the signal electrodes 6 in the leaflet bodies 4. At least one ground electrode 8, which may be located remote from the eyelid stimulator 2, is in electrical contact with the living tissue. The ground electrode 8 is utilized to complete the circuit.
- FIG. 5c illustrates a simplified view of the electrodes connection scheme, where a further alternative embodiment preferably has the individual signal electrodes 6 each connected to the individual signal lead wires 23, such that each signal electrode 6 may be individually powered and controlled.
- the ground electrode 8 may be either locally mounted in the eyelid stimulator 2 or in contact with the living tissue remote from the eyelid stimulator 2.
- FIG. 5d illustrates a simplified view of the electrodes connection scheme, where a further alternative embodiment is described as bipolar pairs, which preferably has individual signal electrodes 6 each connected to individual signal lead wires 23, such that each signal electrode 6 may be individually powered.
- Each signal electrode 6 is paired with a neutral electrode 7, forming a bipolar pair.
- This bipolar pair is powered by an electric pulse generator, such as the implanted miniature electric generator 66, where generator 66a powers one bipolar pair, generator 66b powers a second bipolar pair, etc. It is obvious that one electric generator 66 may power sequentially or simultaneously one or any combination of bipolar pairs.
- the preferred manner of arranging the neutral electrodes 7, shown in FIG. 4 is to attach each neutral electrode 7 to a separate neutral lead wire 22, that in turn passes along and through the leaflet body 4, along and through lead body 10, through seal 18 (see FIGS. 2 and 3), and into insulated neutral cable bundle 16. It is obvious that more than one neutral electrode 7 can be attached to the neutral lead wire 22.
- the signal electrodes 6 are attached to the separate signal lead wire 23 that passes through the leaflet bodies 4 and along the lead body 10, through the seal 18, and into the insulated signal cable bundle 14.
- the lead body 10 is comprised of the top layer 24 and the bottom layer 26.
- the leaflet bodies 4 and the electrode lead body 10 are preferably made of a biocompatible material that is electrically insulating.
- the biocompatible material is silicone having a hardness of about 70 on the Shore A scale as measured with a durometer.
- the insulated signal cable bundle 14 and insulated neutral cable bundle 16 pass through the seal 18, which is attached to the electrode lead body 10.
- the seal 18 is preferably made of silicone.
- the electrode lead body 10 and the leaflet bodies 4 are comprised of a biodegradable material that is resorbed by the body post-implantation. It is obvious that the insulated signal cable bundle 14 and the insulated neutral cable bundle 16 may be combined into one cable bundle.
- An alternative method (not illustrated) of making the eyelid stimulator 2 is to utilize a flexible substrate on which a circuit is printed on one surface that is conformal-coated using biocompatible materials.
- the electrical contact points are made by placing holes through the substrate.
- contact points may be made by masking the conformal coating or photolithographically patterning the conformal coating.
- the signal electrodes 6 are preferably attached by welding to the signal lead wire 23 at signal bond joint 34.
- the neutral electrodes 7 are attached by welding to the neutral lead wire 22 at neutral bond joint 36.
- the leaflet bodies 4 are comprised of the top layer 24 and the bottom layer 26, which are bonded together (see FIG. 4). Sandwiched between the top layer 24 and the bottom layer 26 is a separation layer 28.
- the separation layer 28 is preferably comprised of an electrically insulating material that is soft and biocompatible. In a preferred embodiment, the separation layer 28 is silicone having a hardness of about 70 on the Shore A scale as measured with a durometer.
- FIG. 6 illustrates an alternative embodiment of an eyelid stimulator 37, wherein flexible leg electrodes 40 are contained within flexible legs 38.
- the eyelid stimulator 37 has a generally sinusoidal shape with rounded ends.
- the flexible legs 38 are connected by flexible joints 44, which provide flexibility for the apparatus to conform to the eyelid while maintaining electrical contact with the living tissue as it moves during muscle contraction.
- the flexible leg electrodes 40 are located with apertures 41 in the flexible legs 38.
- the flexible leg electrodes 40 make contact with the nerve or muscle tissue that is to be stimulated by contacting it through the apertures 41 in the flexible legs 38.
- the flexible leg 38 is made of a material, such as silicon, which has a hardness of about 25 on the Shore A scale as measured with a durometer.
- the eyelid stimulator 37 is very flexible, allowing it to move and flex with the muscle as it responds to the electrical stimulation.
- An advantage of this embodiment is that the eyelid stimulator 37 is very soft and flexible, easily conforming to the shape of the eyelid.
- the eyelid stimulator 37 is preferably oriented in the eyelid such that the flexible legs 38 lay across the orbicularis oculi muscle 50 (see FIG. 1). As the orbicularis oculi muscle 50 contracts due to the applied electrical stimulation, the flexible legs 38 move freely with the muscle.
- the flexible leg electrodes 40 may be positive, negative, or neutral biased, depending upon which wire in cable bundle 42 is attached to the flexible leg electrodes 40.
- FIG. 7 illustrates an exemplary open loop control system of the present invention wherein an implanted eyelid stimulator 62 is located in an eyelid.
- the implanted miniature electric generator 66 is located in an implanted position under the skin of the patient near the implanted eyelid stimulator 62 and connected to it by a transmission wire 64.
- the implanted miniature electric generator 66 is controlled by internal programming to generate an electric pulse on a programmed schedule at regular or irregular intervals.
- the implanted miniature electric generator 66 may receive an electric signal from a remote controller (not illustrated) to generate an electric pulse. Examples of known pulse generators are disclosed by U.S. Patent Nos. 6,185,452; 6,208,894; and 6,315,721.
- a further alternative embodiment combines the controller with the implanted eyelid stimulator 62.
- This embodiment is not illustrated.
- the controller exemplified by electric generator 66, is mounted on and therefore is a part of eyelid stimulator 62. More than one stimulator 62, having a controller integrally mounted thereon, may be connected with other similar stimulators 62.
- Known examples of miniature electric pulse generators are disclosed in U.S. Patent No. 5,999,848, incorporated in its entirety by reference herein, which describes an implantable sensor/stimulator connectable to a controller.
- FIG. 8 illustrates an exemplary open loop control scheme 100 that coordinates stimulation between a functioning eyelid 111 and a paralyzed eyelid 109 via an implanted eyelid stimulator 112, located in the paralyzed eyelid 109.
- the implanted eyelid stimulator 112 is controlled by an implanted miniature electric pulse generator 104 via a transmission wire 110.
- the electric pulse generator 104, transmission wire 110, and eyelid stimulator 112 in combination form a stimulating device.
- Known examples of miniature electric pulse generators are disclosed in U.S. Patent Nos. 6,164,284; 6,185,452; 6,208,894; and 6,315,721, each of which is incorporated in its entirety by reference herein.
- the implanted eyelid stimulator 112 may be located on the nerves or on the muscles to cause the eyelid to open or to close.
- the miniature electric pulse generator 104 and control microsensor 102 are typical of the miniature monitoring and/or stimulating devices for implantation in living tissue disclosed by Schulman et al. (U.S. Patent No. 6,164,284), Schulman et al. (U.S. Patent No. 6,185,452), and Schulman et al. (U.S. Patent No. 6,208,894), each of which is incorporated in its entirety by reference.
- connection 108 between the control microsensor 102 and the implanted miniature electric pulse generator 104 may be sent by wireless means, such as by RF signals, propagated radio signals, or alternating magnetic fields.
- wireless means such as by RF signals, propagated radio signals, or alternating magnetic fields.
- FIG. 9 illustrates an embodiment wherein a master control unit 116 may control one or more implanted miniature electric pulse generators 104, to control opening and/or closing of the paralyzed eyelid 109 in a timing sequence determined by the master control unit 116.
- a master control unit 116 may control one or more implanted miniature electric pulse generators 104, to control opening and/or closing of the paralyzed eyelid 109 in a timing sequence determined by the master control unit 116.
- FIG. 9 illustrates an embodiment where there is one paralyzed eyelid 109 and one functioning eyelid 111. Closing the functioning eyelid 111 causes an electric signal to be generated that triggers the implanted eyelid pulse generators 104 to close the paralyzed eyelid 109.
- a further embodiment is a closed loop control scheme 101 that uses a signal from the paralyzed eyelid 109, which is preferably detected by an implanted eyelid sensor electrode 118 to modify the electric signal that closes the paralyzed eyelid 109. For example, if the paralyzed eyelid 109 fails to close properly, then the electric pulse is increased (in amplitude and/or duration) to properly stimulate the eyelid 109 to close. The electric feedback signal is generated when the paralyzed eyelid 109 closes. Eyelid closure is detected by implanted eyelid sensor electrode 118 and is transmitted to an implanted miniature electric pulse sensor 120. A signal is then transmitted to the control microsensor 102 via a connection 122.
- AMD By virtue of having the eyelid stimulated, the additional benefit of therapeutic electrical stimulation to the eye and/or the retina can be achieved.
Abstract
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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EP02739717A EP1404405B1 (fr) | 2001-06-18 | 2002-06-05 | Matrice et systeme de stimulation miniatures implantables con us pour la stimulation de la paupiere |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
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US29937901P | 2001-06-18 | 2001-06-18 | |
US60/299,379 | 2001-06-18 | ||
US10/160,804 US6792314B2 (en) | 2001-06-18 | 2002-05-31 | Miniature implantable array and stimulation system suitable for eyelid stimulation |
US10/160,804 | 2002-05-31 |
Publications (2)
Publication Number | Publication Date |
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WO2002102455A1 true WO2002102455A1 (fr) | 2002-12-27 |
WO2002102455A8 WO2002102455A8 (fr) | 2004-05-21 |
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PCT/US2002/017852 WO2002102455A1 (fr) | 2001-06-18 | 2002-06-05 | Matrice et systeme de stimulation miniatures implantables conçus pour la stimulation de la paupiere |
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US (1) | US6792314B2 (fr) |
EP (1) | EP1404405B1 (fr) |
WO (1) | WO2002102455A1 (fr) |
Cited By (3)
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EP1648554A2 (fr) * | 2003-06-26 | 2006-04-26 | Northstar Neuroscience, Inc. | Appareils et systemes permettant d'appliquer une stimulation electrique chez un patient |
JP2015513980A (ja) * | 2012-04-05 | 2015-05-18 | ザ リージェンツ オブ ザ ユニバーシティ オブ カリフォルニア | 脳神経刺激のための皮下電極 |
WO2021069058A1 (fr) * | 2019-10-07 | 2021-04-15 | Abuyousef Nuha Awni | Système, dispositif et procédé permettant d'induire un mouvement de paupière |
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- 2002-06-05 WO PCT/US2002/017852 patent/WO2002102455A1/fr not_active Application Discontinuation
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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EP1648554A2 (fr) * | 2003-06-26 | 2006-04-26 | Northstar Neuroscience, Inc. | Appareils et systemes permettant d'appliquer une stimulation electrique chez un patient |
EP1648554A4 (fr) * | 2003-06-26 | 2009-06-24 | Northstar Neuroscience Inc | Appareils et systemes permettant d'appliquer une stimulation electrique chez un patient |
JP2015513980A (ja) * | 2012-04-05 | 2015-05-18 | ザ リージェンツ オブ ザ ユニバーシティ オブ カリフォルニア | 脳神経刺激のための皮下電極 |
WO2021069058A1 (fr) * | 2019-10-07 | 2021-04-15 | Abuyousef Nuha Awni | Système, dispositif et procédé permettant d'induire un mouvement de paupière |
Also Published As
Publication number | Publication date |
---|---|
EP1404405B1 (fr) | 2012-04-11 |
EP1404405A4 (fr) | 2007-01-03 |
US6792314B2 (en) | 2004-09-14 |
EP1404405A1 (fr) | 2004-04-07 |
WO2002102455A8 (fr) | 2004-05-21 |
US20030023297A1 (en) | 2003-01-30 |
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